ADEpedia-on-OHDSI: A next generation pharmacovigilance signal detection platform using the OHDSI common data model.

Affiliation

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. Electronic address: [Email]

Abstract

Supplementing the Spontaneous Reporting System (SRS) with Electronic Health Record (EHR) data for adverse drug reaction detection could augment sample size, increase population heterogeneity and cross-validate results for pharmacovigilance research. The difference in the underlying data structures and terminologies between SRS and EHR data presents challenges when attempting to integrate the two into a single database. The Observational Health Data Sciences and Informatics (OHDSI) collaboration provides a Common Data Model (CDM) for organizing and standardizing EHR data to support large-scale observational studies. The objective of the study is to develop and evaluate an informatics platform known as ADEpedia-on-OHDSI, where spontaneous reporting data from FDA's Adverse Event Reporting System (FAERS) is converted into the OHDSI CDM format towards building a next generation pharmacovigilance signal detection platform.

Keywords

Data Standardization,ETL tool,FAERS,OHDSI Common Data Model,Pharmacovigilance,

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